warnings
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Nighttime Sleep-Aid
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Nighttime Sleep-Aid
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- DeMoulas Market Basket
- Product type
- HUMAN OTC DRUG
- SPL set ID
- d3f35102-94ed-4da0-9c29-312e5468fa05
- SPL ID
- 1e87d9fb-3c88-4c4e-8a3e-1c8b9458d6fa
- Version
- 4
- Effective date
- 2023-12-29
- Source export date
- 2026-11-06
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:51:24
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M010 | openfda.application_number | |
| brand name | Nighttime Sleep-Aid | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | DeMoulas Market Basket | openfda.manufacturer_name | |
| ndc | package | 53942-522-28 | openfda.package_ndc |
| ndc | product | 53942-522 | openfda.product_ndc |
| ndc11 | package | 53942052228 | derived:openfda.package_ndc |
| rxcui | 1248354 | openfda.rxcui | |
| spl id | 1e87d9fb-3c88-4c4e-8a3e-1c8b9458d6fa | id | |
| spl set id | d3f35102-94ed-4da0-9c29-312e5468fa05 | set_id | |
| unii | TC2D6JAD40 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.